Quality Engineer I
Our client, a leading medical device manufacturer in Munster requires an experienced QE for a contract role to be located in Limerick.
- Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities)
- Provide effective and responsive QA support to Operations to meet their area?s objectives of quality, cost and output.
- Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA?s)
- Drive and implement plant wide quality system improvements.
- Ensure Regulatory compliance in area of responsibility to cGMP?s of all medical device regulatory agencies (e.g. FDA and TUV)
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
- Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques)
- Approval of change requests for product, process and quality system changes.
- Customer complaints and perform internal quality audits.
- Support the implementation of Lean Manufacturing across the site.
Education, Experience and Skills
- Level 8 BSC/BEng degree and Minimum of 2/3 years? experience in a QA role.
- Knowledge of GMP regulated environment and experience in a similar role would be an advantage.
- Good level of technical and analytical expertise to assist in problem solving
- Experience in process improvement methodologies an advantage.(Engineering Essentials TM)
For further information please contact Cliona O?Malley on 091730022 / email@example.com
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